CSV Engineer

Source Group International; Oberwallis; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Source Group International in Switzerland is seeking an experienced CSV professional to lead risk-based validation gap assessments for GMP pharma/biotech OT systems. You will design system-specific validation strategies, perform risk analyses, create traceability and test documentation, and deliver validated state reports.

Travel to Visp up to 2 days per month is required; fluent English is essential. Nice-to-have: ISA-88/95, Kneat, ValGenesis, FDA inspection exposure, and German language

Qualifikationen

• 8+ years of CSV in GMP pharma/biotech with OT/automation experience.
• Hands-on validation of DeltaV systems; full lifecycle documentation.
• Strong knowledge of GAMP 5, 21 CFR Part 11 and EU GMP Annex 11.
• Willing to travel to Visp 2 days per month; fluent English.
• Nice-to-have: ISA-88/ISA-95, Kneat, ValGenesis, FDA inspection experience, German.

Aufgaben

• Reconcile system inventory, intended use, GxP impact, ownership and validation status.
• Develop system-specific validation strategies, requirements, risk assessments, traceability, tests and reports proportionate to critical functionality.
• Assess DeltaV batch, historian, PLC/SCADA and interface controls where in scope, with application SMEs.
• Execute or coordinate approved testing, manage discrepancies, and verify validated state after changes.
• Assemble inspection-retrievable lifecycle packages without backdating or substituting reconstructed documents for original evidence.

Kenntnisse

CSV depth

DeltaV validation

GAMP 5

Part 11 familiarity

CSA risk concepts

Travel readiness

English fluency

Tools

Kneat

ValGenesis

DeltaV system

Jobbeschreibung

Purpose

• Execute risk-based validation gap assessment and remediation for the explicitly approved OT system inventory.

Revised responsibilities

• Reconcile system inventory, intended use, GxP impact, ownership and validation status.
• Develop system-specific validation strategies, requirements, risk assessments, traceability, tests and reports proportionate to critical functionality.
• Assess DeltaV batch, historian, PLC/SCADA and interface controls where in scope, with application SMEs.
• Execute or coordinate approved testing, manage discrepancies, and verify validated state after changes.
• Assemble inspection-retrievable lifecycle packages without backdating or substituting reconstructed documents for original evidence.

Must-have requirements (recruitment)

• 8+ years of CSV in GMP pharma/biotech (or 5+ with substantial OT/automation CSV depth), with substantial experience on OT/automation systems (DCS, SCADA, PLC).
• Hands-on validation of DeltaV systems; full lifecycle authoring and execution (plan to summary report).
• Strong working knowledge of GAMP 5 (Second Edition), 21 CFR Part 11, EU GMP Annex 11 and risk-based assurance (CSA) principles.
• Willing and able to travel to Visp 2 days per month. Fluent English.
• Nice-to-have: ISA-88/ISA-95, electronic validation tools (Kneat, ValGenesis), FDA inspection experience, German.
• CV keywords: CSV, DeltaV validation, GAMP 5 Second Edition, Part 11, Annex 11, CSA, traceability matrix, Kneat, ValGenesis, ISA-88.

Critical competencies

• GMP automation CSV including hands-on DeltaV validation; 8+ years or equivalent demonstrated depth (thresholds under D09).
• GAMP 5 second edition, EU GMP Annex 11/15, relevant Part 11 and GMP electronic-record controls.
• Risk-based test design, batch/recipe/interface controls, deviation management and retrospective gap remediation.
• Clear distinction between FDA CSA guidance for medical-device production/QMS software and applicable pharmaceutical GMP expectations.

CV screening knock-out criteria (screening w/c 19-Oct-2026)

• No OT/automation CSV experience (IT/business-system-only profiles do not qualify).
• No GMP-regulated industry experience.
• Not available to start on 1-Dec-2026, or unable to travel to Visp 2 days per month.

Minimum deliverables

• Approved system-level validation gap assessment and prioritized remediation plan.
• Risk assessments, traceability, approved test protocols/results and validation summary reports for assigned systems.
• Deviation/exception register with disposition and residual-risk statements.

We believe in equal opportunity for all and actively encourage applications from diverse backgrounds, experiences, and perspectives.